Virtual Reality Treadmill Training in Individuals With Traumatic Brain Injury

NCT ID: NCT05721209

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-03
• Study Completion Date: 2026-12-23

Brief Summary

This pilot study aims to determine the feasibility of a virtual reality treadmill training intervention in individuals with Traumatic Brain Injury (TBI). Participants will be stratified based on age into adults' group or older adults' group and then randomized into the virtual reality treadmill training (intervention) group with feedback or the treadmill training (control) group. This pilot study will also provide preliminary evidence on the impact of the virtual reality treadmill training on mobility, balance, fear of falls, fall risk, attention and physical activity in the community in individuals with TBI. The data collected in this pilot study will also help to estimate sample size for subsequent large clinical trial.

Conditions

Traumatic Brain Injury

Study Design

• Allocation Method: NA
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

VRTT With Feedback - Adults

Adults aged 18-65 with TBI. At Week 1 after baseline, participants will begin study intervention on the C-Mill with augmented/virtual reality (AR/VR) guidance. Starting at Week 2, the study intervention on C-Mill will be repeated 3 sessions/week for 8 weeks.

Each one hour session will include about 15 minutes of standing balance training, about 5 minutes of stepping balance training and about 30 minutes of walking training on the C-Mill with AR/VR feedback.

Group Type: EXPERIMENTAL

C-Mill with AR/VR Guidance

Intervention Type: DEVICE

Treadmill training system that is a combination of an instrumented treadmill, front display, and a floor projector, allowing functional gait and balance training. The AR/VR feedback will include computer generated obstacles and objects projected as images on the treadmill. Participants will be asked to use these projections as stepping cues and step on some images of objects while avoiding stepping on the images of obstacles.

Zeno 3-Layer Walkway

Intervention Type: DEVICE

Used to conduct mobility assessments to assess temporal and spatial gait parameters during the 6-minute walk test.

Hunova

Intervention Type: DEVICE

Used to conduct fall-risk assessment.

VRTT With Feedback - Older Adults

Adults aged 65 and older with TBI. At Week 1 after baseline, participants will begin study intervention on the C-Mill with augmented/virtual reality (AR/VR) guidance. Starting at Week 2, the study intervention on C-Mill will be repeated 3 sessions/week for 8 weeks.

Each one hour session will include about 15 minutes of standing balance training, about 5 minutes of stepping balance training and about 30 minutes of walking training on the C-Mill with AR/VR feedback.

Group Type: EXPERIMENTAL

C-Mill with AR/VR Guidance

Intervention Type: DEVICE

Treadmill training system that is a combination of an instrumented treadmill, front display, and a floor projector, allowing functional gait and balance training. The AR/VR feedback will include computer generated obstacles and objects projected as images on the treadmill. Participants will be asked to use these projections as stepping cues and step on some images of objects while avoiding stepping on the images of obstacles.

Zeno 3-Layer Walkway

Intervention Type: DEVICE

Used to conduct mobility assessments to assess temporal and spatial gait parameters during the 6-minute walk test.

Hunova

Intervention Type: DEVICE

Used to conduct fall-risk assessment.

VRTT Without Feedback - Adults

Adults aged 18-65 with TBI. At Week 1 after baseline, participants will begin study intervention on the C-Mill without augmented/virtual reality (AR/VR) guidance. Starting at Week 2, the study intervention on C-Mill will be repeated 3 sessions/week for 8 weeks.

Each one hour session will include about 15 minutes of standing balance training, about 5 minutes of stepping balance training and about 30 minutes of walking training on the C-Mill without AR/VR feedback.

Group Type: ACTIVE_COMPARATOR

C-Mill without AR/VR Guidance

Intervention Type: DEVICE

Treadmill training system that is a combination of an instrumented treadmill, front display, and a floor projector, allowing functional gait and balance training.

Zeno 3-Layer Walkway

Intervention Type: DEVICE

Used to conduct mobility assessments to assess temporal and spatial gait parameters during the 6-minute walk test.

Hunova

Intervention Type: DEVICE

Used to conduct fall-risk assessment.

VRTT Without Feedback - Older Adults

Adults aged 65 and older with TBI. At Week 1 after baseline, participants will begin study intervention on the C-Mill without augmented/virtual reality (AR/VR) guidance. Starting at Week 2, the study intervention on C-Mill will be repeated 3 sessions/week for 8 weeks.

Each one hour session will include about 15 minutes of standing balance training, about 5 minutes of stepping balance training and about 30 minutes of walking training on the C-Mill without AR/VR feedback.

Group Type: ACTIVE_COMPARATOR

C-Mill without AR/VR Guidance

Intervention Type: DEVICE

Treadmill training system that is a combination of an instrumented treadmill, front display, and a floor projector, allowing functional gait and balance training.

Zeno 3-Layer Walkway

Intervention Type: DEVICE

Used to conduct mobility assessments to assess temporal and spatial gait parameters during the 6-minute walk test.

Hunova

Intervention Type: DEVICE

Used to conduct fall-risk assessment.

Interventions

C-Mill with AR/VR Guidance

Treadmill training system that is a combination of an instrumented treadmill, front display, and a floor projector, allowing functional gait and balance training. The AR/VR feedback will include computer generated obstacles and objects projected as images on the treadmill. Participants will be asked to use these projections as stepping cues and step on some images of objects while avoiding stepping on the images of obstacles.

Intervention Type: DEVICE

C-Mill without AR/VR Guidance

Treadmill training system that is a combination of an instrumented treadmill, front display, and a floor projector, allowing functional gait and balance training.

Intervention Type: DEVICE

Zeno 3-Layer Walkway

Used to conduct mobility assessments to assess temporal and spatial gait parameters during the 6-minute walk test.

Intervention Type: DEVICE

Hunova

Used to conduct fall-risk assessment.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. 18 to 90 years old

2. diagnosed with a non-penetrating TBI

3. at least 12 months post most recent injury

4. self-reported balance deficits and fear of falls or at least 2 falls in the last one year

5. Able to understand and speak English language to respond, understand and comply with study procedures throughout the 10-week study period and fill out the study questionnaires in English

6. Able to walk with minimal assistance or less (with bracing and assistive devices as needed)

Exclusion Criteria

1. history of severe cardiac disease

2. neuromuscular or neurological pathologies other than TBI that limit study participation

3. uncontrolled seizure disorder

4. weight greater than 135 kg or less than 25 kg

5. height greater than 6' 2''

6. severe cognitive, visual or hearing impairment where the patient is not able to follow the study instructions

7. open skin lesion or bandage in the area of C-Mill harness contact

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Akhila Veerubhotla, PhD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

NYU Langone Health

New York, New York, United States

Countries

United States

Other Identifiers

22-01576

Identifier Type: -

Identifier Source: org_study_id